For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency, and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Adamis, Algernon, Apellis, Diamedica, Everest, Icanomab, Immunitybio, Ix, Kiromic, Mindmed, Pharmather, RDIF.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Astellas, Bridgebio, Creative Medical Technology, Pharmaessentia.
The potential for using real-world data (RWD) to support the development of cancer drugs for children has yet to be realized as researchers, sponsors and regulators continue to struggle with the collection of meaningful data.
More than 150 U.S. patents could be at stake if the World Trade Organization (WTO) were to adopt an intellectual property waiver as originally proposed by India and South Africa.
It took a few years and three tries, but Heron Therapeutics Inc. finally got its pain drug, HTX-011, now branded Zynrelef, over the FDA finish line. Even so, the approval comes with a less broad label than Heron would have liked. Zynrelef (bupivacaine and meloxicam), which had a May 12 PDUFA date, is approved for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annovis, Antengene, Ascendis, Heron, Palisade, RDIF, Strongbridge.
It came as no surprise May 12 that the CDC’s Advisory Committee on Immunization Practices (ACIP) voted 14-0, with one recusal, to recommend the use of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), in 12- to 15-year-olds following the FDA’s decision earlier this week to expand the vaccine’s emergency use authorization (EUA) to that age group.
An international task force launched in March to identify new approaches for analyzing and addressing competitive concerns arising from biopharma M&As is now seeking public comment to inform their review.
While acknowledging the net health benefit over standard of care in heavily pretreated multiple myeloma patients, CAR T-cell therapies Abecma (idecabtagene vicleucel) and ciltacabtagene autoleucel (cilta-cel) represent low long-term value at their current pricing levels, according to the Institute for Clinical and Economic Review (ICER) in a final evidence report released May 11.
RSS
